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Fusobacterium Nucleatum at Colorectal Cancer Sites

Primary Purpose

Colorectal Cancer, Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
biopsy
Sponsored by
Malmö University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of colorectal cancer

Sites / Locations

  • Skane University HospitalRecruiting

Outcomes

Primary Outcome Measures

Presence of F.nucleatum in a colon cancer biopsy
dichotomous (present / absent)

Secondary Outcome Measures

Full Information

First Posted
July 3, 2023
Last Updated
July 11, 2023
Sponsor
Malmö University
Collaborators
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05945082
Brief Title
Fusobacterium Nucleatum at Colorectal Cancer Sites
Official Title
Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malmö University
Collaborators
Skane University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Recent studies suggest an association of periodontitis with an overall increased cancer risk but also with cancer development in specific anatomic regions, such as in the colon. The gut microbiome in general and specifically Fusobacterium nucleatum have been described to likely affect colorectal cancer (CRC) development. The present project intends to evaluate the possible contribution of the oral cavity as a reservoir for dissemination of F.nucleatum to the colon. Additionally, the gut microbiome and dietary intake will be assessed as possible factors influencing colonization of CRC sites with F. nucleatum and an association of F.nucleatum colonization in the colon with parameters in the saliva and serum will be tested. One-hundred-fifty patients diagnosed with CRC will be included; after cancer diagnosis and before starting cancer treatment a periodontal examination will be done and saliva and serum samples and at the time-point of tumor resection a biopsy of the CRC sites will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Periodontitis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
biopsy
Intervention Description
biopsy of a colorectal cancer site
Primary Outcome Measure Information:
Title
Presence of F.nucleatum in a colon cancer biopsy
Description
dichotomous (present / absent)
Time Frame
At timepoint of biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of colorectal cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Bertl
Phone
00436645151194
Email
kristina.bertl@mau.se
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Stavropoulos
Email
andreas.stavropoulos@mau.se
Facility Information:
Facility Name
Skane University Hospital
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klas Sjöberg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Fusobacterium Nucleatum at Colorectal Cancer Sites

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